Amendments to Articles 4 and 19 of the 
Regulations Governing Border Inspection and 
Examination of Imported Medical Devices
Article 4 In accordance with the provisions of Paragraph 1 of Article 52 of
this Act, to apply to import the medical devices mentioned in the
preceding Article, the obligatory inspection applicant shall file an
inspection application form with the following documents to the
inspection authority at the port where the medical devices are to
be imported 15 days prior to the date of inspection:
1. A copy of the medical device license or listing, or approval
document to import the medical devices as a special case.
2. A copy of application for import declaration.
3. Other documents and information designation by the central
competent authority.
If  the  afore-mentioned  application  is  to  be  filed  by  a
representative, an identification document for the representative
and a letter of power of attorney shall be provided, unless the
obligatory inspection applicant can provide a copy of the long-
term  entrustment  agreement  and  has  notified  the  inspection
authority of the entrustment.The central competent authority may require the obligatory
inspection applicant to submit the application of the preceding
paragraph electronically.
In the event that the inspection authority discovers that the
application  documents  and  information  are  not  complete,  the
inspection  authority  shall  notify  the  obligatory  inspection
applicant who shall make corrections within 20 days. In the event
that the applicant fails to make corrections before the designated
deadline, the application shall be rejected.
Article 19 These regulations shall be implemented on May 1st, 2021.
These regulations are amended on July O, 2022 and shall take
effect upon the date of publication.Attachment 1 of Article 3 of Regulations 
Governing Border Inspection and Examination of 
Imported Medical Devices--List of amendments
Attachment 1
Item
No.Item NameClassification
CodeChinese Name English Name
14014.10.00.10 L.5300衛生套（保險套） Condom
24014.10.00.90 L.5310含殺精劑的衛生套Condom with 
spermicidal lubricant
36307.90.50.31-A I.4040一般醫用口罩 General medical mask
46307.90.50.31-B I.4040外科手術口罩 Surgical mask
56307.90.50.31-C I.4040N95醫用口罩N95 medical mask
63002.15.00.10 B.4020COVID-19家用型
抗原檢測試劑COVID-19 Antigen 
Home/Self TestAttachment 2 of Article 6 of Regulations 
Governing Border Inspection and Examination of 
Imported Medical Devices--List of Amendments
Attachment 2: Verification items, test items  and testing methods of imported medical
devices.
Attachment 1: Item No. 1: Condom; Item No. 2: Condom with spermicidal lubricant
1. Verification item: Name and address of the manufacturer (labeling shall be completed 
before importation; a letter from the original manufacturer shall be 
attached when the documents are not in English.)
2. Test items and testing methods: Randomly select 315 samples when the batch has 
500,000 (or less) units and 500 samples when the batch 
has 500,001 (or more) and perform the following 
examination:
Test item Testing methods
Appearance In accordance with CNS 6629 T2008
Pin-hole test In accordance with CNS 6629 T2008Attachment 1: Item No. 3: General medical masks, Item No. 4: Surgical mask, Item No. 5: 
N95 medical mask
1. Verification item: Name and address of the manufacturer (labeling shall be completed 
before importation; a letter from the original manufacturer shall be 
attached when the documents are not in English.)
2. Test items and testing methods: Randomly select 100 samples from each batch and 
perform the following examination:
General medical mask
Test item Testing methods
Bacterial filtration efficiency (BFE) In accordance with CNS 14774
pressure difference In accordance with CNS 14774
Surgical mask
Test item Testing methods
Sub-micron particulate filtration
efficiency testIn accordance with CNS 14774
pressure difference In accordance with CNS 14774
N95 medical mask
Test item Testing methods
Sub-micron particulate filtration
efficiency testIn accordance with CNS 14755
Respiratory impedance In accordance with CNS 14755Attachment 1: Item No. 6: COVID-19 Antigen Home/Self Test
1. Verification item: Name and address of the manufacturer (labeling shall be 
completed before importation; a letter from the original manufacturer 
shall be attached when the documents are not in English.)
2. Test items and testing methods: Randomly select 100 samples from each batch and 
perform the following examination:
Test item Testing methods
Analytical reactivity test of
diagnostic reagentAppropriate virus strains are used to confirm if the positive
and negative result of the product is correct
Detection limit of the diagnostic
reagentThe claimed detection limit for positivity will be tested with
appropriate viral concentration.